Heart, blood pressure drugs recall slammed

A recall of a blood pressure and heart medicine used by over 60,0000 Irish patients has “caused consternation”, with pharmacists inundated with patient requests for alternatives at a time when the supply of unaffected medicines is constrained.

Kerry TD and pharmacist John Brassil, who has a pharmacy in Ballyheigue, said yesterday was dominated by a stream of patients to his premises seeking an alternative to the recalled medicines which contain the active ingredient valsartan. The impurity N-nitrosodimethylamine (NDMA), a probable carcinogen, was found in the manufacturing process in a valsartan active substance at a plant in China.

He said each patient query took around 20 minutes to deal with and that about 30 patients came to his pharmacy yesterday worried that their blood pressure or heart failure medicine was causing them harm.

He said pharmacists were hamstrung in providing an alternative because they cannot write prescriptions.

He said the likelihood was that GP surgeries were also swamped with patients seeking new prescriptions and that the Health Products Regulatory Authority (HPRA), which issued the recall on Thursday, had handled the issue very badly.

He said the HPRA had issued the public recall notice without giving pharmacists any time to prepare a response. This difficulty was compounded by the fact that the initial recall letter, issued at 3pm on Thursday, had in many cases appeared in spam email folders.

The authority acknowledged this yesterday in an “urgent” follow-up email to pharmacists, saying: “We have been alerted to the fact that many of those [recall] emails have appeared in spam folders and many pharmacists would not have been immediately aware of this communication.

“As this is an important patient safety matter, requiring pharmacist action, that recall letter is attached again and linked in this email for your attention.”

The authority also acknowledges in its follow-up that the supply of unaffected valsartan-containing medicines “is severely constrained at this time and is working with the manufacturers and wholesalers in relation to the supply issue”.

Moreover, while new stocks of unaffected medicines are expected to be available in Ireland next week, the HPRA has warned that “the supply situation will remain a significant issue for a period of time”.

Mr Brassil said it was also a concern that a pharmacist recall only, and not a patient recall, had been instigated.

“In other words, while we stop selling the product and quarantine it for return to the wholesaler, we don’t have to contact the patient,” he said.

“But if they come into me I have to tell them to stop taking it and find an alternative — which I can’t prescribe. They are then going to their GP which is putting a further strain on an already stressed system. And GPs have not been given guidelines as to what to do.

“The HPRA should have put a protocol in place before issuing the recall.”